Mastering your 510(k) submission process

Bringing a Class II medical device to the American market? You’ll need to go through the 510(k) process, your gateway to FDA clearance. Yet many businesses are getting it wrong: successful applications are falling, and 30% of 2021 applications weren’t even accepted for initial review.

A robust 510(k) plan is crucial for a smooth and speedy route to market. This webinar gives you everything you need to know to become a 510(k) master.


  • Understand the optimal pathway to follow for right-first-time, stress-free 510(k) clearance
  • Learn the most common mistakes the FDA sees in applications, and how to avoid them
  • Unpick the key ingredients of a 510(k) submission, from predicate devices and substantial equivalence to typical timelines


Kyle Rose, President

Rook Quality Systems

Kyle Rose is a Medical Device expert specializing in the development of efficient Quality Systems for startup to large medical device companies. Kyle founded Rook Quality Systems in 2012 to enable clients to implement compliant Quality Management Systems, and to ensure that clients can efficiently produce effective and reliable medical devices. Rook has been overseeing overall quality strategy and ensuring compliance through documentation and auditing services for over a decade.

Kyle is a certified quality auditor (CQA) and has regulatory and submission experience for a variety of markets including FDA, CE Mark, Health Canada, and CFDA. Kyle encourages the simplification of Quality Systems to reduce the quality burden and to improve compliance through training and efficient QS design.